FDA 510(k) clearances — page 168
clearances on record, most recent first.
Clearances — page 168
16,701–16,800 of 175,699- K211275 — AirMax Procedure Mask
- K211313 — MAXFRAME Multi-Axial Correction System (aka MAXFRAME)
- K211460 — Air Relax Plus Model AR-3.0
- K210214 — NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System
- K210425 — Catalyft PL Expandable Interbody System
- K210535 — UltraLight LED System
- K210975 — Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia
- K211246 — LEGION CR Porous Plus HA Femoral Components
- K190703 — Neuro-IOM system with Neuro-IOM.NET software
- K201192 — Impla-NX (Model: ISE-270M)
- K201461 — Manual Wheelchair, Model A011
- K202299 — Ultrasonic Surgical Aspirator System
- K202359 — Zio Monitor
- K202527 — Zio ECG Utilization Software (ZEUS) System
- K203806 — JWX-1 Plus (Navigo 16/Navigo 24)
- K210119 — IPL Hair Removal Device (Model: KCA423)
- K210358 — Neurescue device
- K211273 — Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray
- K211312 — Universal Viewer
- K211423 — Rover
- K202716 — Ignite Anatomic Shoulder System
- K202899 — Procedure Mask, Surgical Mask
- K202919 — ATS 5000 Automatic Tourniquet Instrument
- K203331 — Quick-20m
- K203377 — VR101 Lubricating Intravaginal Ring
- K203415 — Surgical Isolation Gown
- K203440 — Penumbra System (Reperfusion Catheter RED 62)
- K203583 — YUWELL infrared ear thermometer: YHT101, YHT200
- K210086 — Vitals360 Multi-Vitals Mobile Monitor
- K210257 — Xoran Workstation, Model 10050
- K210476 — EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy Needle
- K210581 — Actis DuoFix Hip Prosthesis- Collarless
- K211001 — C-Qual M Breastboard; Monarch Overhead Arm Positioner
- K201569 — CUVIS-spine
- K201576 — Disposable Latex Powder Free Examination Gloves (Non-sterile)
- K202593 — Turbett Instrument Pod
- K202866 — TENS & EMS Device
- K202955 — Contour Light CL-100
- K203282 — TECHFIT Patient-Specific Maxillofacial System
- K210187 — Overjet Dental Assist
- K210237 — CINA CHEST
- K210306 — GII Spinal Fixation System
- K210394 — Electrosurgical accessory
- K210540 — Ohlendorf Clear Aligner
- K210553 — Steam-Dot Process Indicator
- K210880 — Vereos PET/CT
- K202423 — MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 µg/mL)
- K202458 — BonOs Inject, Pedicle screw kits, Cement pusher
- K202667 — Personal Lubricant Jelly
- K202709 — Disposable Powered Endoscopic Linear Cutting Staplers and Cartridges
- K210816 — True Tulip, True M.I.S.
- K210829 — Persona Revision Knee System Femoral Metaphyseal Cones
- K202793 — Cercare Medical Neurosuite
- K203682 — Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and Divider, Double Action
- K210217 — Needleless Connector
- K210460 — NitriTec Vinyl Glove Powder Free Blue
- K211037 — Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
- K211105 — Ear-Friendly Mask
- K200573 — BoneTrust Mini Implant System
- K202138 — Cardiac Trigger Monitor
- K202747 — Klarity Bolus
- K202862 — Gx-IVF, Gx-TL, Gx-MOPS PLUS
- K203226 — TELESCOPE 0 O 10MM WL 305MM / TELESCOPE 30 O 10MM WL 305MM / TELESCOPE 50 O 10MM WL 305MM, TELESCOPE 0 O 10MM WL 440MM / TELESCOPE 30 O 10MM WL 440MM / TELESCOPE 50 O 10MM WL 440MM
- K210072 — HOLOSCOPE-i
- K210200 — 1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock
- K210302 — Disposable Medical mask
- K210417 — Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL
- K210774 — Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
- K210780 — Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
- K210799 — Powder Free Vinyl Patient Examination Gloves
- K210942 — MicroFrance Monopolar and Bipolar Electrosurgical Instruments
- K211100 — AcQGuide MAX Steerable Sheath
- K211130 — NPseal
- K200555 — Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner)
- K202697 — United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Mask, United Sewing High Fluid Resistant Procedure Mask
- K202924 — LinkSymphoKnee System
- K203481 — CryoVIVE
- K203566 — Tablet Application
- K210369 — Powder Free Nitrile Examination Glove
- K210426 — HS40 Diagnostic Ultrasound System
- K210485 — PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC Family)
- K210815 — Disposable Face Mask
- K210874 — Reliance Spinal Screw System
- K210979 — Prelivia
- K211004 — GMK Spherika Femurs and Fixed Tibial Trays Plus
- K211115 — A1AT Genotyping Test
- K211118 — SIGNA 7.0T
- K210153 — NextAR RSA Platform
- K210435 — Automatic Arm Electronic Blood Pressure Monitor
- K210439 — NuVasive MOD-EX XLIF Interbody System
- K210557 — Symbia VA10A Family
- K210689 — ClotTriever Thrombectomy System
- K210737 — SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate
- K210809 — iTotal® Identity Cruciate Retaining (CR) Knee Replacement System (KRS)
- K210974 — High Performance Antimicrobial Gelling Fiber with Silver
- K202272 — HD Mediastinoscope
- K202860 — Valley Contax Single Vision (SV) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax Goldeneye Aspheric Front Multifocal (AFM) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax V Kone (VK) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A)
- K202973 — HANAROSTENT Benefit Biliary (NNN)
- K203228 — DART-FIRE EDGE Cannulated Screw System
- K210572 — Neurodyn V2.0, Neurodyn Aussie V2.0
Data sourced from openFDA. This site is unofficial and independent of the FDA.